FDA Launches New Quality/Compliance Web Content

FDA's Office of Compliance and Biologics Quality (QCBQ) within the Center for Biologics Evaluation and Research (CBER) has launched a web page describing responsibilities such as inspection, surveillance, and compliance to pre- and post- market approval activities.

PPTA News

PPTA Repeats Appeals for Plasma Donations +

The Plasma Protein Therapeutics Association is steadfast in its mission to promote the availability of, and access to, safe and effective plasma protein therapies for patients around the world. We call on all eligible adults to donate plasma – whether you are someone recovered from COVID-19 or not, your plasma is needed to save lives, now. By donating plasma today, you are directly helping to save the lives of babies born with primary immune deficiencies, bleeding disorders, and other rare conditions, as well as patients who rely on plasma therapies in emergency and critical-care contexts.
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White House Roundtable: “We’re in this Together” +

Yesterday, President Trump, senior officials within his Administration, and representatives from the plasma and blood communities agreed that plasma donation is a national imperative, recognizing how essential plasma is and urging Americans to donate their plasma. Paul Perreault, Chief Executive Officer and Managing Director of CSL Ltd. represented the CoVIg-19 Alliance, “an unprecedented partnership of world-leading companies” dedicated to the development of a hyperimmune globulin with the potential to treat people seriously impacted by COVID-19. He took the opportunity presented by participating in the White House Roundtable to issue a call for all Americans to donate plasma, even those who have not had COVID-19, and to urge the Administration to support the industry’s effort to develop a hyperimmune to combat COVID-19.
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PPTA Responds to July 24 White House Executive Orders +

White House executive orders issued on July 24 calling for a “favored nations” and drug importation program are ill-advised and risk the lives of U.S. patients who rely on access to plasma protein therapies. These unique, non-interchangeable and lifesaving therapies treat patients with rare diseases such as primary immune deficiency and bleeding disorders, like hemophilia. The executive order on favored nations would use pricing schemes from countries that often do not make the PPTs used by U.S. patients available, often selecting only one representative drug in a category and artificially setting prices.
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EU Health Commissioner Says Plasma Donation is “More Important Than Ever” +

The Plasma Protein Therapeutics Association (PPTA) welcomes EU Health Commissioner Kyriakides’ recognition of the importance of plasma donation in her observance yesterday of World Blood Donor Day. By noting plasma’s role in the manufacture of plasma-derived medicinal therapies (PDMPs) for people with a range of life-challenging diseases, as well as its potential role in treating people with COVID-19, Commissioner Kyriakides rightly notes that “donating plasma is therefore now more important than ever.”
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The Source, the international magazine of the plasma protein therapeutics industry, is published quarterly.

Learn more about the need for plasma donors, plasma donation, and how you can save and improve lives. Find a Donation Center.

"How Is Your Day?" is an initiative to raise awareness of the unique nature of plasma protein therapies and the value they provide to patients. It aims to inform and educate decision makers and the general public worldwide.

Get involved and follow "How Is Your Day?" on social media @HIYDglobal

FDA Launches New Quality/Compliance Web Content

PPTA Repeats Appeals for Plasma Donations +

White House Roundtable: “We’re in this Together” +

PPTA Responds to July 24 White House Executive Orders +

EU Health Commissioner Says Plasma Donation is “More Important Than Ever” +

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